RecruitingPhase 1

A Study on the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of SKB500 in Subjects With Advanced Solid Tumors

China180 participantsStarted 2024-12-13

Plain-language summary

This study aims to evaluate the safety, tolerability, PK profile, immunogenicity, and antitumor activity of SKB500 in subjects with advanced solid tumors.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female participants between 18 and 75 years old.
✓. Histologically or cytologically confirmed advanced solid tumors for which standard treatment either does not exist or has proven ineffective or intolerable.
✓. Subjects should ideally provide a tumor tissue sample for biomarker testing during the screening period.
✓. Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
✓. ECOG performance status score of 0 or 1.
✓. Expected survival of at least 12 weeks.
✓. Has adequate hematopoietic, renal and hepatic functions.
✓. Have recovered to grade ≤ 1 of prior anti-cancer treatment toxicities.

Exclusion criteria

✕. Subjects with known active CNS metastases, carcinomatous meningitis, leptomeningeal metastases, or spinal cord compression.
✕. Subjects with other malignancies within 5 years before the first dose.
✕. Any severe and/or uncontrolled concurrent disease that may interfere with the subject's participation in the study.
✕. Active hepatitis B, or hepatitis C; active tuberculosis, or human immunodeficiency virus (HIV) test positive, or known acquired immunodeficiency syndrome (AIDS).
✕. History of allergy to any component of SKB500 or history of severe hypersensitivity reactions to other monoclonal antibodies.
✕. Subjects with a history of interstitial lung disease, non-infectious pneumonia, or other pulmonary diseases significantly affecting lung function.
✕. History of allogeneic organ transplantation or hematopoietic stem cell transplantation.
✕. Uncontrolled pleural effusion, ascites, or pericardial effusion.

What they're measuring

Evaluate the incidence of adverse events (AEs)

Timeframe: Up to 3 years

Evaluate the incidence of serious adverse events (SAEs)

Timeframe: Up to 3 years

Evaluate the incidence of treatment related adverse events (TRAEs)

Timeframe: Up to 3 years

Evaluate the incidence of dose-limiting toxicities (DLTs)

Timeframe: Day 1 to Day 21 in Cycle 1 in the dose escalation part

Trial details

NCT IDNCT06736327

SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07-31

Contact for this trial

Yan Qing

028-67255480 qingyan@kelun.com

View on ClinicalTrials.gov More Advanced Solid Tumors trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female participants between 18 and 75 years old.
✓. Histologically or cytologically confirmed advanced solid tumors for which standard treatment either does not exist or has proven ineffective or intolerable.
✓. Subjects should ideally provide a tumor tissue sample for biomarker testing during the screening period.
✓. Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
✓. ECOG performance status score of 0 or 1.
✓. Expected survival of at least 12 weeks.
✓. Has adequate hematopoietic, renal and hepatic functions.
✓. Have recovered to grade ≤ 1 of prior anti-cancer treatment toxicities.

Exclusion criteria

✕. Subjects with known active CNS metastases, carcinomatous meningitis, leptomeningeal metastases, or spinal cord compression.
✕. Subjects with other malignancies within 5 years before the first dose.
✕. Any severe and/or uncontrolled concurrent disease that may interfere with the subject's participation in the study.
✕. Active hepatitis B, or hepatitis C; active tuberculosis, or human immunodeficiency virus (HIV) test positive, or known acquired immunodeficiency syndrome (AIDS).
✕. History of allergy to any component of SKB500 or history of severe hypersensitivity reactions to other monoclonal antibodies.
✕. Subjects with a history of interstitial lung disease, non-infectious pneumonia, or other pulmonary diseases significantly affecting lung function.
✕. History of allogeneic organ transplantation or hematopoietic stem cell transplantation.
✕. Uncontrolled pleural effusion, ascites, or pericardial effusion.

What they're measuring

Evaluate the incidence of adverse events (AEs)

Timeframe: Up to 3 years

Evaluate the incidence of serious adverse events (SAEs)

Timeframe: Up to 3 years

Evaluate the incidence of treatment related adverse events (TRAEs)

Timeframe: Up to 3 years

Evaluate the incidence of dose-limiting toxicities (DLTs)

Timeframe: Day 1 to Day 21 in Cycle 1 in the dose escalation part